Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published June 18, 2025

Medtronic CareLink SmartSync Patient Connector Software Recall: Risk of Unintended Therapy

Medtronic recalls specific software versions of CareLink SmartSync Patient Connector Model 24967 due to a risk of unintended high-voltage therapy delivery during induction tests. Affected units may not properly cancel high-voltage treatments if the Abort button fails to stop the test.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2168-2025Medical deviceMedtronic ›
Take action

Contact the company

Recalling firmMedtronic, Inc.8200 Coral Sea St Ne · Mounds View, MN 55112-4391
✎ GovInfoNow plain-language explainer

Medtronic is recalling CareLink SmartSync Patient Connector Model 24967 with certain software versions because a flaw in the Abort button could prevent users from canceling high-voltage therapy during induction tests. This risk means users might not be able to stop a potentially harmful treatment if they need to abort the test. Read more at govinfonow.com/recall/52013-medtronic-carelink-smartsync-patient-connector-software-recall-risk-of-unintended.

Source Summary by GovInfoNow · govinfonow.com/recall/52013-medtronic-carelink-smartsync-patient-connector-software-recall-risk-of-unintended · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2168-2025

Cite this page

“Medtronic CareLink SmartSync Patient Connector Software Recall: Risk of Unintended Therapy.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52013-medtronic-carelink-smartsync-patient-connector-software-recall-risk-of-unintended. Based on FDA recall #Z-2168-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2168-2025%22&limit=1).

The FDA announced on June 18, 2025, that Medtronic, Inc. is recalling the Medtronic CareLink SmartSync Patient Connector, Model Number 24967, due to a software hazard. The recall affects devices distributed worldwide and in the U.S. nationwide.

How to tell if you have it

  • Medtronic CareLink Smartsync Patient Connector, Model Number 24967
  • Cobalt Crome application, Software Model Number D00U005
  • Claria Amplia Compia application, Software Model Number D00U009
  • Evera MRI application, Software Model Number D00U010
  • Visia AF application, Software Model Number D00U011
  • Viva Brava Evera application, Software Model Number D00U012
  • Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5
  • Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5
  • Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2
  • Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6
  • Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6
  • Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5
  • Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2
  • Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2
  • Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2
  • Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2
  • Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5

The hazard

According to the FDA, in prior SmartSync application versions, the Abort button stopped the selected test. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Context

GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Other recent recalls of similar products include Medtronic Sphere-9 Catheter Recall (2026-03-11), Medtronic Abre Venous Stent Recall (2025-12-04), and Medtronic EVX 60 Series - Medical Devices (2025-10-29). Other recent recalls of similar products include Medtronic Restore CP App Model A71100 Software Issue (2025-11-20), Medline Medical Kits Recall (2026-02-27), and Medline Basic Nerve Block Tray Recall (2026-01-07).

How to tell if you have this one

Check if your CareLink SmartSync Patient Connector has Model Number 24967 and the listed software versions (D00U003 to D00U012). The product was sold with specific software updates between 2020 and 2023.

  • Brand
    Medtronic
  • Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution.
Recall numberProduct, codes & lots
Z-2168-2025Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;; 1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.
Z-2169-2025Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;; 1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Identify your software version by checking the device settings or documentation for the specific software model numbers listed in the recall.

  2. Update Software

    Update to the latest software version (D00U012) or contact Medtronic for a software update if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Jun 18, 202512. FDA classified it Class II: Jul 23, 202523. Published in FDA’s Enforcement Report: Jul 30, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using my device?

No, you do not need to stop using the device immediately. Updating the software resolves the issue, so continued use is safe after the update.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Other Medtronic recalls

Medtronic Inc. recalls Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and
November 21, 2019

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2168-2025 (June 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2168-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA